Biopharma Raw Materials QA Specialist – Quality & Compliance

KBI Biopharma, Inc.; Durham (NC); On-site; USD 85,000 - 105,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Specialist, Quality Assurance Raw Materials (QARM) to ensure quality and regulatory compliance for raw materials used in clinical and commercial manufacturing.

This role provides QA oversight in a cGMP environment and partners with suppliers to support timely material release and investigations. The Specialist collaborates with Manufacturing, Supply Chain, Quality Control, and external suppliers to maintain material quality, manage supplier

Qualifications

• Quality documentation review and quality impact assessments
• Raw material release and supplier quality oversight
• Quality systems support
• Supply chain and operational quality partnership
• Retain and inventory management

Responsibilities

• Quality documentation review and approval of specs, procedures, and change controls.
• Oversee raw material release and supplier qualification activities, ensuring timely disposition.
• Support deviations, investigations, CAPAs, and changes impacting QA RM and incoming material processes.
• Collaborate with Supply Chain, Procurement, and Manufacturing to maintain material supply and quality risk controls.
• Manage retention of raw materials, client cell bank inventories, and drug substance retains.

Job description

KBI Biopharma, Inc. in Durham, NC is seeking a Specialist, Quality Assurance Raw Materials (QARM) to ensure quality and regulatory compliance for raw materials used in clinical and commercial manufacturing.

This role provides QA oversight in a cGMP environment and partners with suppliers to support timely material release and investigations. The Specialist collaborates with Manufacturing, Supply Chain, Quality Control, and external suppliers to maintain material quality, manage supplier